Multiple MyelomaPhase 1NCT03448978
Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
A Phase 1 study testing Descartes-08, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Cartesian Therapeutics at 3 sites in United States.
Trial summary
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Descartes-08, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Mar 2018to 3 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
- Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells.
- Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%)
Who cannot join
- NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary
- Active plasma cell leukemia
- Pregnant or lactating
- Active, uncontrolled infection
- Active and severe auto-immune disease
- Active arrhythmia, or obstructive or restrictive pulmonary disease
- Central nervous system disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Virgina Cancer Specialists
Fairfax, Virginia, 22031
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Descartes-08, Fludarabine, Cyclophosphamide
- Keywords
- Descartes-08, CAR T Cell, CART, CAR-T, CAR T-Cell, Multiple Myeloma, BCMA, B-cell maturation antigen, B cell maturation antigen
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descartes-08Biological
Also called CAR-T cells
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
FludarabineDrug
intravenous fludarabine
CyclophosphamideDrug
intravenous cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Descartes-08 plus fludarabine/cyclophosphamide pretreat | Experimental | Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor Receives: Biological: Descartes-08; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]
Measured: 2 weeks
Secondary outcomes (1)
Treatment response
IMWG treatment response criteria
Measured: 1, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start8 Mar 2018
- Primary completion19 Apr 2021
- Study completion3 Jun 2021
Why it stopped: Phase 1 enrollment completed. Further clinical development terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartesian Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Metin Kurtoglu, MD, PhD, Study director, Cartesian Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448978
- Sponsor's protocol ID
- 241-59-88
- Status last verified
- Jun 2024
- First submitted
- 24 Jan 2018
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03448978
- Acronym / sponsor ID
- 241-59-88
- Conditions
- Multiple Myeloma
- Keywords
- Descartes-08, CAR T Cell, CART, CAR-T, CAR T-Cell, Multiple Myeloma, BCMA, B-cell maturation antigen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 1 enrollment completed. Further clinical development terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cartesian TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Descartes-08 plus fludarabine/cyclophosphamide pretreat | Experimental | Biological: Descartes-08, Drug: Fludarabine, Drug: CyclophosphamideAutologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
- Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells.
- Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%)
Key exclusion criteria (7 listed)
- NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary
- Active plasma cell leukemia
- Pregnant or lactating
- Active, uncontrolled infection
- Active and severe auto-immune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Descartes-08Also: CAR-T cellsautologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor | Biological | Descartes-08 plus fludarabine/cyclophosphamide pretreat |
| Fludarabineintravenous fludarabine | Drug | Descartes-08 plus fludarabine/cyclophosphamide pretreat |
| Cyclophosphamideintravenous cyclophosphamide | Drug | Descartes-08 plus fludarabine/cyclophosphamide pretreat |
Primary outcome
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2 weeks
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]
1 secondary outcome
Treatment response
Time frame: 1, 3, 6, 9 and 12 months
Results and safety
The study was stopped early (reason given: Phase 1 enrollment completed. Further clinical development terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metin Kurtoglu, MD, PhD study director
Cartesian Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Descartes-08, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Cartesian Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Phase 1 enrollment completed. Further clinical development terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.